Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury

A Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial for Efficacy in the Use of Adjuntive Probiotic Therapy in Reducing Urinary Tract Infections in Those Individual With Spinal Cord Injury

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00594594

Enrollment

Registered

2008-01-15

Start date

2007-09-30

Completion date

2009-05-31

Last updated

2009-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury, Urinary Tract Infections

Keywords

spinal cord injury, urinary tract infection, probiotics, Lactobacilli

Brief summary

We hypothesize that probiotic Lactobacillus can augment antibiotic treatment of symptomatic urinary tract infection (UTI) in spinal cord injured patients, and also increase the time to the next episode of UTI.

Detailed description

Subjects will be recruited from the outpatient population and 'alumni' of the Regional SCI Rehabilitation Programs in London (Parkwood Hospital/St Joseph's Health Care) and Hamilton (Hamilton Health Sciences Centre) Ontario. Community living paraplegic and tetraplegic men and women (18 years and above) who present to their family physician or specialist with symptomatic UTI will be prescribed an antibiotic treatment for up to 14 days (using the drug of choice i.e. which the treating physician deems appropriate) and randomized to also receive by mouth two capsules containing placebo or probiotic Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 daily.

Interventions

OTHERProbiotic Lactobacillus GR-1 and RC-14

Two capsules of Lactobacillus GR-1 and RC-14 daily for 12 months

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Spinal cord injury * UTI * \> 18years * Male and females * Prescribed antibiotics

Exclusion criteria

* Patients who are participating in another clinical study involving pharmaceutical products. * Patients who are participating in other urology clinical study. * Patients taking yogurt containing probiotic lactobacilli during the period of the study. * Females who are pregnant and/or planning to get pregnant during the study period

Design outcomes

Primary

Measure	Time frame
Increase time to next UTI	12 months

Secondary

Measure	Time frame
Numbers of infections of any type occurring during probiotic treatment	12 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026